CTRI/2024/04/065776
Not yet recruiting
未知
A Prospective Observational Study to evaluate the Gut Microbiome status in Indian advanced Non-Small Cell Lung Cancer Patients receiving Immunotherapy and investigate potential correlations between the gut microbiome composition and treatment outcomes - NI
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: C34- Malignant neoplasm of bronchus andlung
- Sponsor
- Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Those who were willing to participate (via written consent form) in the study.
- •2\. Histologically confirmed diagnosis of non\-small cell lung cancer (NSCLC).
- •3\. Age more than 18 years at the time of the study.
- •4\. PD\-L1 tumor expression more than 1 percent
- •5\. Adequate performance status (e.g., ECOG performance status of 0\-2\).
- •6\. Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1\.1 (RECIST v1\.1\)
- •7\. Prior systemic treatment for metastatic NSCLC will be allowed
- •8\. Willingness and ability to undergo stool sample collection for gut microbiome analysis.
- •9\. Patients scheduled to receive immunotherapy as part of their treatment.
- •10\. Adequate organ function (e.g., liver, kidney, hematological parameters) to tolerate immunotherapy.
Exclusion Criteria
- •1\. Previous exposure to immunotherapy or other immune checkpoint inhibitors.
- •2\. Presence of other active malignancies or history of recent cancer treatment.
- •3\. History of autoimmune diseases or immunodeficiency disorders.
- •4\. Current use of antibiotics, probiotics, or other medications known to significantly affect the gut microbiome.
- •5\. Severe gastrointestinal disorders or conditions that may impact gut microbiota composition (e.g., inflammatory bowel disease).
- •6\. Inability to provide informed consent or comply with study procedures.
- •7\. Contraindications to undergoing stool sample collection or microbial analysis (e.g., active gastrointestinal bleeding, recent bowel surgery).
Outcomes
Primary Outcomes
Not specified
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